Memorandum by the Ministry of Agriculture,
Fisheries and Food, the Department of Health, Scottish Office,
Welsh Office and Northern Ireland Office

INTRODUCTION

1. The Government aims to protect public health
in relation to food by promoting and enforcing high standards
of food safety as a matter of paramount importance at all stages
in the production, processing and supply of food. It is committed
to openness and transparency in the way it works and consults
fully with all interested groups affected by its activities. The
Government recognises the many potential benefits that genetic
modification offers to agriculture and ultimately to consumers.
Examples include a reduction in the quantities of herbicides through
the development of herbicide tolerant plants, the production of
insect resistant or disease resistant crops and the production
of medicinal products using animals. Consumers stand to gain from
foods that are more nutritious, tastier, more plentiful and cheaper.
Therefore, provided that all GM foods have been thoroughly assessed
for safety, the Government believes that consumers should be allowed
to choose whether to purchase them or not. For this to be possible
all foods containing GM materials must be clearly labelled. The
recently agreed EC Regulation on the labelling of GM soya and
maize will help to make sure this requirement is met. The only
GM foods currently on the market are a vegetarian cheese made
using the enzyme chymosin obtained from a GM organism, a GM tomato
paste, and foods containing ingredients from GM soya and maize.
Oils produced from GM oil seed rape is likely to be the next product
on the market. The Government will continue to ensure that GM
products are regulated in an appropriate manner and that the regulatory
framework is kept under regular review.

GMO LEGISLATION

2. There is a comprehensive UK regulatory framework,
based on EU legislation, covering all stages of work with genetically
modified organisms (GMOs) designed to protect human health and
the environment. This consists of the EC Contained Use Directive
(90/219) dealing with all aspects of the development of GM Micro
Organisms prior to their release into the environment, the EC
Deliberate Release Directive (90/220) which lays down environmental
safety controls for releases and marketing for GMOs and the Novel
Foods and Novel Food Ingredients Regulation (258/97) which covers
all aspects of the use of GM technology for the production of
foods. In Great Britain, the competent authorities for the first
two Directives are the Health and Safety Executive and the Department
of the Environment, Transport and the Regions who will deal with
their respective Directives in their memoranda. The Novel Foods
and Novel Food Ingredients Regulation and associated controls
are described in more detail in the following paragraphs.

GENETICALLYMODIFIEDFOODS

The EC Novel Foods Regulation 258/97

3. The EC Novel Foods Regulation (258/97) came
into force on 15 May 1997, following extensive consultation between
Member States. The then UK Government also conducted a series
of consultations with industry and consumer groups at various
stages of the Regulation's development. The Regulation established
an EU wide pre-market approval system for all novel foods, that
is foods which have not hitherto been used for human consumption
to a significant degree in the EU before, including foods containing
or produced from genetically modified organisms (GMOs). Where
an application is for a food or food ingredient that contains
or consists of a GMO, the application will also need to include
an environmental risk assessment in line with the requirements
of Directive 90/220/EEC. The Regulation also lays down general
labelling requirements (see paragraph 9).

4. The Novel Foods Regulation is enforced in
the UK by The Novel Foods and Novel Food Ingredients Regulations
1997, which lay down offences and penalties. These also designate
the Minister of Agriculture, Fisheries and Food and the Secretary
of State for Health, acting jointly, as the competent food assessment
authority in the UK. The Novel Foods and Novel Food Ingredients
(Fees) Regulations 1997 make provisions for charges to be set
for assessment of novel foods and novel food ingredients applications.
DETR and the Advisory Committee on Releases into the Environment
(ACRE) will be consulted on the environmental risk assessment,
under arrangements set out in a Memorandum of Understanding.

Safety Assessment of Novel Foods

5. In the UK we have considerable experience
of assessing the safety of novel foods, including those produced
using genetic modification, stretching back over some 10 years.
These assessments are carried out by the Advisory Committee on
Novel Foods and Processes (ACNFP), a body of independent experts
whose expertise is acknowledged world-wide. The safety assessment
is based on the concept of substantial equivalence which involves
a comparison of a GM food with its conventional equivalent and
a detailed examination of any differences. Where there is no equivalent,
all aspects of the novel food are examined in detail. This approach
has been endorsed by the World Health Organisation and is widely
used by regulatory authorities around the world. Applications
currently under consideration by the Committee are for processed
products from two GM cotton seeds (cotton seed oil) (one developed
to be insect protected and the other to be herbicide tolerant),
one GM maize (developed to be both insect protected and herbicide
tolerant) and one GM potato (developed to be insect protected).

6. The ACNFP includes amongst its members an
ethicist and a consumer representative. More general issues, including
labelling, are referred as necessary to the Food Advisory Committee
(FAC). This Committee has a broader membership than the ACNFP
consisting of those with backgrounds in food, enforcement, advertising
standards, consumer affairs, manufacturing and retailing, and
academia and is therefore well equipped to deal with any matters
requiring a wider perspective.

7. The ACNFP has for some time published the
agendas and a note of the outcome of each of its meetings as well
as detailed reports of its assessments and an annual report (copy
of 1996 report attached). [not printed]. More recently
however it has begun to publish the minutes of its meetings. It
has also been agreed that papers discussed at the meetings will
be made available on request and a Newsletter will be published.
It has also decided to hold open meetings on topics of wider interest
so as to provide as much opportunity as possible for people to
learn about, and contribute to, the issues that it is dealing
with. In this way, it is hoping to encourage interested parties,
including members of the public, to make more of an input into
its deliberations.

8. One such meeting of a subgroup of the ACNFP
was recently held to examine the possibility of setting up post-market
surveillance arrangements for monitoring any long term affects
of novel foods on public health as an additional safeguard. This
was also attended by industry, pressure groups and consumer observers.
The meeting proved extremely useful and a number of ideas emerged
which are in the process of being followed up.

Labelling of GM Foods

9. The Government is determined that all foods
which contain GM ingredients should be clearly labelled so that
consumers know what they are buying. The Novel Foods Regulation
requires specific labelling when a food is judged, on the basis
of a scientific assessment, not to be equivalent to an existing
food. Food will also require labelling if there are any health
or ethical concerns or if it contains a GMO. The EC has recently
adopted a Regulation laying down detailed rules for the labelling
of GM soya and maize, which will come into force in September.
This requires all foods containing ingredients produced from Monsanto's
GM soya and Novartis' GM maize to be labelled except when neither
protein nor DNA resulting from genetic modification is present.
This is likely to set a precedent for the way all future GM foods
will need to be labelled. The Regulation incorporates a number
of requirements put forward by the UK during its Presidency of
the EU.

Segregation

10. A number of organisations have called for
GM material, such as soya beans, which are produced outside Europe,
to be segregated from conventionally produced products. However,
the Government cannot insist on this as a condition of import
as GM soya has been cleared on safety grounds by all member states
and such a requirement would therefore contravene the rules of
the World Trade Organisation. In recognising these constraints,
the Government has nevertheless been considering what can be done
to help companies who wish to obtain supplies of non-GM soya to
be able to do so. With the co-operation of the Canadian and US
authorities, a list of suppliers and distributors of non-GM soya
has recently been published by MAFF and placed on the Internet.

R&D

11. MAFF has a sizeable (>£1 million
in financial year 1998-99) and expanding programme of research
on the safety of Novel Foods and Releases of GMOs into the Environment.
The objective of this programme is to provide information needed
to safeguard the consumer and the environment from any risks associated
with the consumption of novel foods and the release of food related
GMOs. Research projects to date have fallen into the broad areas
of analysis, labelling and risk evaluation and have covered the
genetic stability of crop and model plant species after transformation,
gene transfer and the implications for safety of novel gene expression.
Projects include work on:

 Methods to detect of GMOs in processed
and unprocessed foods.

 Development of databases on genes
that have been introduced by genetic modification of crops intended
for food use.

 Development of methods to predict
the allergenic potential of genetically modified foods and novel
protein products.

 Investigation of the transfer of
genetic material to gut microflora from ingested GM micro-organisms.

 Investigation of Agrobacterium as
a vehicle of gene escape.

 Investigation of the stability of
expression and inheritance of transgenes.

 Investigation of the effect of background
genotype on transgene expression.

 Increasing the public's understanding
of biotechnology.

GENETICALLYMODIFIEDCROPS

Herbicide Tolerant and Pest Resistant Crops

12. In July 1997, MAFF issued a consultation
paper called "Weed Control on the Farm: Management of Genetically
Modified Herbicide Tolerant Crops" and invited comments from
interested parties. Virtually everyone who responded agreed that
GMHT crops must be properly managed. The commentswhich
are available for reading in MAFF's Main Libraryfell mainly
into three categories; support for an industry code of practice;
support for a moratorium until MAFF-funded research on possible
risks to the agricultural environment from the release of GMHT
crops was complete; or demands for an outright ban on GM crops.
The Government is currently finalising its views and expects to
make an announcement soon. It has however received advice that
there are no legal powers which would allow the Government to
impose a moratorium or a ban on the use of these crops.

R&D

13. In 1990 MAFF started a programme of research
to look at the possible risks to the agricultural environment
from the release of genetically modified organisms. Over £3.5
million has been committed to the programme and, to date, results
have not indicated any risks to the agricultural environment from
the release of GMOs. In 1997, new research on the release of herbicide
tolerant crops was commissioned. The research, with a total budget
of over £500,000, is due to be completed in 2000. Projects
include work on:

 Studies of the local and regional
scale movement of an oil seed rape transgene.

 The role of bees in pollen transport
between sites.

 Consequence analysis of the impact
on agriculture and the environment of the release of herbicide
tolerant oil seed rape.

 Impact of changes in patterns of
herbicide usage on the environment and biodiversity.

 Risk assessment of transgene movement.

 Frequency and impact of transgene
movement by pollen to weed species.

National Listing and plant breeders' rights

14. The Seeds (National Lists of Varieties)
Regulations 1982 as amended implement EC Directive EC 70/457 and
EC 70/458 and provide that varieties of the main agricultural
and horticultural species must be on the UK National list or the
EC Common Catalogue before their seed can be marketed. Varieties
are grown in official tests and trials, normally for two years,
to establish that they are Distinct, Uniform and Stable (DUS)
and have value for cultivation and use (VCU), before they are
Nationally Listed. This system underpins the quality of new agricultural
crops being introduced into the UK.

15. If a plant variety is genetically modified
the quite separate stringent controls under part VI of the Environmental
Protection Act 1990 and Regulations made under it, which implement
Council Directive 90/220/EEC on the deliberate release into the
environment of genetically modified organisms, also apply. Under
these controls, MAFF cannot undertake official tests and trials
unless a consent to release or market has been issued by the Secretary
of State or by another Member State's competent authority. Moreover,
GM plant varieties will not be added to the National List until
all the necessary safety and environmental clearances to permit
marketing are in place.

16. At present, there are no GM varieties on
the UK National List, though MAFF has received applications for
addition of GM varieties of sugar beet (five varieties), maize
(one variety) and oilseed rape (14 varieties). These are at varying
stages in National List tests and trials and the point at which
they might be available commercially varies from application to
application. The earliest point at which seed of GM varieties
(two spring oilseed rapes) could be available for commercial planting
is spring 1999.

17. MAFF is also responsible for the administration
of UK plant breeders' rights. These are an intellectual property
right, akin to patents, but designed specifically to protect plant
varieties. Varieties entered for plant breeders' rights are also
tested for Distinctness, Uniformity and Stability. MAFF is currently
considering 22 applications for plant breeders' rights in respect
of gm oilseed rape varieties (nine of these are combined National
List/plant breeders' rights applications and 13 are for plant
breeders' rights only).

Pesticide approvals

18. Herbicides are controlled, under British
and EC law, as pesticides. Under the pesticides approvals process,
no pesticide may be advertised, sold, supplied, stored or used
unless Ministers have approved that pesticide and consented to
that activity. Applicants for pesticide approval must show that
their products are effective, humane and pose no unacceptable
risks to human beings, non-target species or the wider environment.
Various statutory conditions are attached to pesticide approvals
to protect human and environmental safety. These include the crop
on which the pesticide may be used, maximum dose rates and the
maximum number of applications that can be made. In seeking any
extension of authorisation of a pesticide to include herbicide
tolerant crops necessary safety and efficacy data would have to
be supplied by the applicant. The normal considerations of human
and environmental safety would determine whether such an application
would be granted. At present there are no approvals for the use
of herbicides on GM herbicide tolerant or pest resistant crops.

GENETICALLYMODIFIEDFARMANIMALS

Cloning

19. Research on cloning (nuclear transfer) requires
a licence from the Home Office under the Animals (Scientific Procedures)
Act 1986. Regulations to control the commercial cloning of animals
could be made under the Animal Health and Welfare Act 1984. Cloning
was considered acceptable by the 1995 "Committee to Consider
the Ethical Implications of Emerging Technologies in the Breeding
of Farm Animals" (the Banner Committee). The Farm Animal
Welfare Council has been asked to consider the possible implications
of cloning for the welfare of farmed livestock, and whether any
further moral or ethical issues need to be addressed. Human cloning
is the concern of the UK Human Embryology and Fertilisation Authority
and the Human Genetics Advisory Commission.

Other Genetic Modification Involving Farm Animals

20. MAFF's policy on genetic modification of
farm animals is guided by the recommendation of the Banner Committee
report. The report recognised that existing regulations mean that
genetically modified animals are likely to be more thoroughly
protected than those produced by conventional means.

21. Genetic modification of animals is a regulated
procedure under the Animals (Scientific Procedures) Act 1986 and
requires a licence from the Home Office. The Genetically Modified
Organisms (Contained Use) Regulations 1992 and the Genetically
Modified Organisms (Deliberate Release) Regulations 1992, both
as amended, cover the storage, use, release for research purposes,
marketing, transportation and destruction of genetically modified
animals.

R&D

22. MAFF has been the major supporter of work
on cloning and has funded research at the Roslin Institute on
cloning since 1991 at a cost of over £2 million to date.
An additional £1.3 million has been spent on research into
the problem of oversized offspringa syndrome known to occur
following in vitro fertilisation. MAFF funded the work
because of its potential to contribute towards the genetic improvement
of livestock. Following the scientific breakthrough leading to
Dolly the cloned sheep, MAFF is now focussing research on improving
the efficiency of cloning. Current spend on this by MAFF is £120,000
per year.

23. In the UK there is a view that the benefits
to medicine of producing pharmaceuticals in milk, or of xenografts,
may justify genetic modification of animals. In addition, much
useful information on human (and some animal) diseases is obtained
by creating transgenic animal models of diseases. MAFF is considering
one such project on scrapie. However, with present knowledge,
many people feel that research to improve livestock performance
through genetic modification is not justified. MAFF does not fund
such research.

ANIMALFEEDINGSTUFFS

24. The European Commission is expected to propose
shortly a new Directive covering novel feed materials. This will
provide an opportunity for a specific assessment of the implications
of feeding GM material to animals. Currently in the UK the ACNFP
considers the impact of such feeding on food for the ultimate
consumer. A new Advisory Committee of Animal Feedingstuffs will
consider GM feed materials when it is set up later this year,
liaising closely with the ACNFP.

CONSUMEREDUCATION

25. An important consideration for consumers
when deciding whether to purchase GM foods is an awareness of
what the technology involves. MAFF has always recognised the importance
of providing information about this and first produced a Foodsense
booklet on genetic modification and food in 1995. Last year we
commissioned and part funded a mobile exhibition on food biotechnology
organised by the Science Museum. We are currently considering
a number of further initiatives for disseminating information
about the technology which we hope to put in place later this
year. In the meantime we are actively supporting a public consultation
on biotechnolgy which was announced by the Minister for Science
and Technology last November. This is an important mechanism for
identifying public concerns about the technology.